Trial Search Results

ARrest RESpiraTory Failure From PNEUMONIA

This research study seeks to establish the effectiveness of a combination of an inhaled corticosteroid and a beta agonist compared to placebo for the prevention of acute respiratory failure (ARF) in hospitalized patients with pneumonia and hypoxemia.

Stanford is currently accepting patients for this trial.

Lead Sponsor:

Stanford University

Collaborator: National Heart, Lung, and Blood Institute (NHLBI)

Intervention(s):

  • Drug: Inhaled budesonide and formoterol
  • Drug: Inhaled placebo

Phase:

Phase 3

Eligibility


Inclusion Criteria:

Patients 18 years or older with

   1. Severe Pneumonia defined as hospitalization for acute (defined as ≤ 14 days) onset of
   symptoms (cough, sputum production, or dyspnea) and radiographic evidence of pneumonia
   by chest radiograph or CT scan AND evidence of systemic inflammation (temperature <
   35◦C or > 38◦C OR WBC > or < upper or lower limits for site OR procalcitonin > 0.5
   mcg/L), OR known current immunosuppression preventing inflammatory response.

   AND

   2. Hypoxemia defined as new requirement for daytime supplemental oxygen with SpO2 < 92%
   on room air, ≤ 96% on ≥ 2 L/min oxygen, or > 6L/min or non-invasive ventilation
   regardless of SpO2 at enrollment. Patients admitted with pneumonia but not meeting
   criteria for hypoxemia will be followed for up to 24 hours from ED admission to
   enrolling hospital to assess for development of qualifying hypoxemia.

Exclusion Criteria:

   1. Inability to obtain consent within 24 hours of presentation to enrolling hospital (up
   to 12 hours allowed at transferring ED for maximum of 36 hours from presentation)

   2. Intubation (or impending intubation) prior to enrollment

   a. Patients receiving HFNC oxygen or NIV prior to enrollment are not excluded

   3. A condition requiring inhaled corticosteroids or beta-agonists (patients receiving
   inhaled beta-agonists in the ED without an established indication will be eligible if
   treating clinician is willing to discontinue subsequent treatments)

   4. Chronic systemic steroid therapy equivalent to >10 mg prednisone

   5. COVID-19 positive patients receiving > 6 mg dexamethasone (30 mg prednisone equivalent
   dose)

   6. Non-COVID-19 pneumonia patients receiving systemic steroid > 10 mg prednisone except
   for stress dose steroids for septic shock

   7. Chronic lung or neuromuscular disease requiring daytime oxygen or mechanical
   ventilation other than for obstructive sleep apnea (OSA) or obesity hypoventilation
   syndrome

   8. Not anticipated to survive > 48 hours or not expected to require > 48 hours of
   hospitalization

   9. Contraindication or allergy to inhaled corticosteroids or beta-agonists

10. Patients with heart rate > 130 bpm, ventricular tachycardia or new supraventricular
   tachycardia within last 4 hours will be potentially eligible for enrollment after the
   condition has resolved

11. K+ < 3.0 will be potentially eligible for enrollment after the condition has resolved

12. Patient not committed to full support other than intubation or resuscitation (i.e.,
   DNR/DNI status allowed)

13. Pregnancy

14. Incarcerated individual

15. Physician refusal of consent to protocol

16. Patient/surrogate refusal of consent to protocol

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Joe Levitt, MD
650-723-6381
Recruiting